Vaginal remodeling device and method

ABSTRACT

This invention provides devices and methods for remodeling the female genital tissue, the device comprising a treatment tip, wherein the distal end of the treatment tip is conical, spherical, hemispherical, oval or circular in shape. The device further comprises one or more energy delivery elements for simultaneous cooling of the vaginal epithelium and transmission of energy for heating the tissues underneath the epithelium. In one embodiment, said device may further comprise one or more of the following: one or more temperature sensors for measuring the temperature at or below the epithelium; one or more directional sensors mounted on the hand piece or treatment tip; and one or more depth markers to show the depth of penetration of the treatment tip into the vagina. In another embodiment, this invention provides a device having a finger holder with electrodes for remodeling the female genital tissue.

RELATED APPLICATION

This application claims the priority of Chinese application201210069906.X, filed Mar. 16, 2012. The entire contents and disclosuresof this prior application are incorporated herein by reference into thisapplication.

FIELD OF THE INVENTION

This invention relates to devices and methods for remodeling tissue ofthe vagina and vulva, for example, by the application of radiant energy.

BACKGROUND OF THE INVENTION

The vaginal tissue of women is stretched during vaginal child birth; atleast some of the effects of the stretching are permanent and many womenhave long term medical consequences. Some consequences may includesexual aspects, as may follow from excessive loosening of the vagina andits opening. Such loosening typically occurs with the first vaginaldelivery, and the loosening tends to increase with subsequent vaginaldeliveries. The effect of looseness in this region may include decreasedpressure and friction during intercourse, and as a consequence,decreased sexual pleasure for women and their conjugal partners. Somesurgical options can be exercised in an attempt to alleviate theseproblems. However, these surgical approaches are not highly popularbecause of the risks associated with an invasive procedure.

Known systems and devices for treating the vagina are less than optimal,including those using radiant energy to modify the collagen. Inparticular, known systems are not optimized for the manipulation of thedevice and the cooling of the treated tissue. In addition, existingsystems may not regulate the contact with the patient's tissueoptimally. Finally, known systems have not proven to be simple,lightweight or intuitive to use. Described herein are systems anddevices that can solve all the above-mentioned insufficiencies of knownsystems.

SUMMARY OF THE INVENTION

This invention provides a device and system for remodeling the femalegenital tissue, the device comprising a treatment tip and one or moreenergy delivery elements for simultaneous cooling of the vaginalepithelium and transmission of energy for heating the tissues underneaththe epithelium. The device may further comprises one or more temperaturesensors for measuring the temperature at or below the epithelium; one ormore directional sensors mounted on the hand piece or treatment tip; andone or more depth markers to show the depth of penetration of thetreatment tip into the vagina. In another embodiment, this inventionprovides a device having a finger holder with electrodes for remodelingthe female genital tissue.

DETAILED DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of one embodiment of the device comprisinga treatment tip (1), a hand piece (2) and a connection means (3),wherein said treatment tip has a cone-shaped distal end, wherein energydelivery elements (4) are arranged over the curved surface of the cone.

FIGS. 2A and 2B are perspective views of another embodiment of a devicecomprising a hand piece connected to a treatment tip that has aspherical distal end.

FIG. 3A indicates cross-sections A-A and B-B in an embodiment of adevice comprising a cone-shaped treatment tip. FIG. 3B illustrates oneembodiment of a coolant spray pattern in the internal cooling chamber(5) of a cone-shaped treatment tip, showing some of the nozzles (6).FIGS. 3C and 3D are close-up views of a coolant spray pattern, showingthe energy delivery elements (4).

FIG. 4 illustrates one embodiment of a hand piece.

FIGS. 5A and 5B show two views of an integrated system for tissueremodeling.

FIG. 6A shows one embodiment of a treatment device with a temperaturesensor (11) that is adapted to measure temperature on the surface of thegenital epithelium. FIGS. 6B and 6C show other embodiments of atreatment device with temperature sensors adapted to measure temperaturebeneath the surface of the genital epithelium.

FIG. 7A shows one embodiment of a directional sensor (7) mounted on thedistal end of a hand piece; FIG. 7B shows one embodiment of adirectional sensor (7) mounted on the proximal end of a hand piece; FIG.7C shows one embodiment of a directional sensor (7) mounted on thetreatment tip.

FIG. 8A shows some depth markers (8) on the treatment surface of atreatment tip having a cone-shaped distal end; FIG. 8B shows some depthmarkers (8) on the treatment surface of a treatment tip having arectangular distal end; FIG. 8C shows some raised and indented depthmarkers on the treatment surface of a treatment tip having a rectangulardistal end.

FIG. 9 shows one embodiment of a device having a finger holder withelectrodes for remodeling female genital tissue, said device comprisinga gripping means (14), a hand piece (2), a wrapping loop (15), a housing(13) and a wire (16).

FIG. 10 shows one embodiment of a device having a finger holder forremodeling female genital tissue, wherein said finger holder (12) iscoupled through a connection means (3) to a hand piece (2).

DETAILED DESCRIPTION OF THE INVENTION

Described herein are devices and systems for remodeling target tissuesunderlying the epithelium of female genital tissue, while cooling theepithelium. The systems consist of devices that work together as aremodeling tool. In one embodiment, the device includes a hand piece anda treatment tip, which may form part of a system further including apower source, a source of coolant, and a control system.

The present invention provides a device which is a component of systemsfor remodeling target tissues underlying the epithelium of femalegenital tissue (hereinafter called ‘systems’).

The device in the present invention comprises a treatment tip (1) and ahand piece (2), wherein the treatment tip (1) is coupled through aconnection means (3) to the distal end of the hand piece (2), whereinthe distal end of the treatment tip is conical, spherical,hemispherical, oval or circular in shape, wherein the device furthercomprises one or more of the following: one or more temperature sensors(11) for measuring the temperature at or below the epithelium; one ormore directional sensors (7); and one or more depth markers (8) showingthe depth of penetration of the treatment tip into the vagina.

In another embodiment, the device in the present invention comprises atreatment tip (1) and a hand piece (2), wherein the treatment tip iscoupled through a connection means (3) to the distal end of the handpiece, wherein the device comprises one or more temperature sensors (11)for measuring the temperature at or below the epithelium, wherein thedevice further comprises one or more directional sensors (7) mounted onthe hand piece or treatment tip. In one embodiment, the distal end ofthe treatment tip is rectangular, curved, conical, spherical, oval,hemispherical or circular in shape.

The distal end of the treatment tip comprises one or more energydelivery elements (4) comprising an internal surface and anepithelium-contacting surface.

The inside of the distal end of said treatment tip (1) comprises aninternal cooling chamber (5) having a plurality of nozzles (6)configured to spray a coolant onto the internal surface of the energydelivery elements. Said internal cooling chamber may comprise a coolantreturn line that vents used coolant from the treatment tip.

The energy delivery element comprises at least one radiofrequency (RF)electrode.

The surface of the distal end of the treatment tip may be fully coveredby the energy delivery elements, or has one or more areas not covered bythe energy delivery elements.

In one embodiment, the energy delivery elements can be turned on and offin a specific sequence, or in a clockwise or counter-clockwisedirection.

The energy delivery elements can cool the vaginal epithelium andsimultaneously transmit energy for heating the target tissues.

In one embodiment, the treatment tip can be removably attached to thehand piece of a system so as to receive electricity, radiofrequency,coolant and/or digital signals.

In one embodiment, the temperature sensors are thermocouples. Forexample, each thermocouple comprises a first and a second junction. Inone embodiment, the first junction is located on the hand piece orbetween the energy delivery elements and said hand piece. In anotherembodiment, the second junction is located at the distal end, proximalend, or middle of the energy delivery elements.

In one embodiment, the second junction comprises a blunt end thatcontacts the epithelium and measures its temperature, or a needle thatpenetrates the epithelium and measures the temperature underneath theepithelium.

Directional sensors generally provide information for tracking theposition of the treatment tip. In one embodiment, directional sensorsemploy electromagnetic or optical mechanisms to track the position ofthe treatment tip. Directional sensors can be mounted on variouspositions such as the proximal or distal end on the hand piece or closeto the energy delivery elements on the treatment tip.

In one embodiment, the surface of the treatment tip comprises depthmarkers, wherein the surface can be rectangular, curved, conical,spherical, hemispherical, oval or circular in shape. In one embodiment,the depth markers comprise numerical markings.

In another embodiment, the depth markers on the treatment tip or itssurface comprise raised lines, indented lines or numerical markings. Inanother embodiment, the depth markers are located on more than one sideof the treatment tip.

In another embodiment, the present invention provides a device having afinger holder fitted with electrodes for remodeling female genitaltissue, said device comprising a gripping means (14) and a hand piece(2), wherein the gripping means is connected to the hand piece, whereinthe gripping means has a finger holder (12) at the proximal end, and awrapping loop (15) at the distal end, wherein the finger holder isattached to a housing (13), and the surface of the housing comprises atleast one energy delivery element (4), wherein the device furthercomprises one or more of the following: one or more temperature sensors(11); one or more directional sensors (7); and one or more depth markers(8). In one embodiment, the finger holder and hand piece are connectedvia wires (16) for delivery of electricity, radiofrequency, coolant ordigital signals.

In one embodiment, the present invention provides a device having afinger holder with electrodes for remodeling female genital tissue, saiddevice comprising a finger holder (12), a hand piece (2) and aconnection means (3), wherein the finger holder is coupled through theconnection means to the distal end of the hand piece, wherein the fingerholder is connected to a housing (13), and the surface of the housingcomprises at least one energy delivery dement (4), wherein the devicefurther comprises one or more of the following: one or more temperaturesensors (11); one or more said directional sensors (7); and one or moresaid depth markers (8).

The above-mentioned energy delivery element comprises an internalsurface and an epithelium-contacting surface. In one embodiment, theenergy delivery elements comprise at least one radiofrequency (RF)electrode.

The housing (13) is rectangular, curved, oval, conical, hemispherical,spherical or circular in shape. In one embodiment, the housing comprisesan internal cooling chamber (5) having a supply line of coolant oppositeto the internal surface of the energy delivery elements, wherein thesupply line of coolant comprises a plurality of nozzles (6) configuredto spray a coolant onto the internal surface of the energy deliveryelements.

In another embodiment, the present invention provides a system forremodeling female genital tissue (hereinafter called ‘system’). In oneembodiment, the system comprises the treatment tip described above, ahand piece, and an integrated controller that comprises, for example, ahousing, a radiofrequency generator within the housing, a coolingsub-system within the housing, and a controller for controlling theoperation of the system.

This invention further provides a method of using the above device orsystem for remodeling a target tissue underlying a mucosal epithelium ofthe female genital tissue, comprising the step of cooling saidepithelium and heating said target tissue with energy-delivery elementsof the device or system. The content of PCT/US2010/049045 is herebyincorporated by reference in its entirety into this specification toillustrate a method of remodeling the female genital tissue.

The method may comprise a step of connecting the treatment tip to anelongated handle configured to be held by two hands. The method may alsocomprise a step of confirming contact of the energy delivery elementswith the tissue based on the temperature at or near the energy deliveryelements and the time since the treatment tip is last activated.

In one embodiment, the step of cooling the epithelium comprises sprayingcoolant onto the internal surface of the energy delivery elements,wherein the coolant may be recycled.

In said method, the target tissue may be heated to a temperature betweenabout 45° C. and about 80° C. by applying energy from the energydelivery dements. In one embodiment, the method comprises cooling theepithelium to a temperature between about 0° C. and about 10° C. Thecooling may precede the heating, and continue during the heating.Alternatively, cooling is performed during heating, and continues afterheating.

In one embodiment, the method comprises contacting the epithelium withthe treatment tip at one or more contact sites during a procedure.

In said method, the female genitalia include the vulva, the vagina andthe introitus. The female genitalia may also include a portion of thevagina extending from the introitus inwardly from about 1 cm to about3.5 cm. The female genitalia may include a portion of the vaginacircumferentially around its wall from about 1 o'clock to about 11o'clock, wherein the aspect closest to the urethra is at 12 o'clock. Inone embodiment, the female genitalia includes a portion radiatingoutwardly from the introitus to the Hart's line. In another embodiment,the female genitalia includes the mucosal surfaces of the labia minora.

In said method, the target tissue includes submucosa and muscularisbelow the mucosal epithelium. In one embodiment, the heating does notsubstantially modify the mucosal epithelium of the genital tissue. Inanother embodiment, remodeling comprises contracting the target tissue,tightening the introitus, tightening the vagina, denaturing collagen, ortightening the collagen-rich sites in the target tissue.

This invention will be better understood by reference to the exampleswhich follow. However, one skilled in the art will readily appreciatethat the examples provided are merely for illustrative purposes and arenot meant to limit the scope of the invention which is defined by theclaims following thereafter.

Throughout this application, it is to be noted that the transitionalterm “comprising”, which is synonymous with “including”, “containing” or“characterized by”, is inclusive or open-ended, and does not excludeadditional, un-recited elements or method steps.

EXAMPLES Device for Remodeling Genital Tissues

In one embodiment, a device for remodeling female genital tissuecomprises a hand piece and a treatment tip (FIGS. 1-2). The hand pieceis adapted to be held by an operator, such as a physician. The handpiece may include connections to a larger supporting system, or it maybe operable as a self-sufficient independent device. In one embodiment,the treatment tip can be configured to be removably coupled to the handpiece, for example, the treatment tip can be designed as a quickconnect/disconnect unit with respect to its attachment to the handpiece.

Treatment Tip

In one embodiment, the treatment tip comprises a housing, a midsection,and a treatment surface at the distal end of the treatment tip, whereinthe treatment surface is covered by one or more energy delivery elementsthat each comprises an internal surface and an epithelium-contactingsurface. The energy delivery elements are adapted to allow cooling ofthe epithelium while transmitting energy to heat the target tissue. Thehousing defines an interior space which extends forward to the distalend of the treatment tip. The midsection of the treatment tip provides afunctional advantage in that it allows the energy delivery elements tobe projected forward from the body of the hand piece. The overall lengthof the treatment tip can be designed to reach the innermost region ofthe vagina that is to be treated.

Energy Delivery Element

In one embodiment, each energy delivery element has an internal surfacefacing the interior space within the treatment tip, and anepithelium-contacting surface facing the exterior of the treatment tip.The internal surface may be made of a metal, e.g. copper, gold, silver,or aluminum. The epithelium-contacting surface may comprise a variety ofdifferent materials, including but not limited to, polyimides, Teflon®,silicon nitride, polysilanes, polysilazanes, Kapton and similarpolymers, antenna dielectrics and other dielectric materials known inthe art. Other exemplary dielectric materials include polymers such aspolyester, silicon, sapphire, diamond, zirconium-toughened alumina(ZTA), alumina and the like. In another embodiment, the energy deliverydement is made of a composite material, including but not limited to,gold-plated copper, copper-polyimide, silicon/silicon-nitride and thelike.

In one embodiment, the energy delivery element may he a radiofrequencyelectrode, a microwave emitter, or an ultrasound emitter. For example,the radiofrequency electrode is a capacitive electrode that couples tothe epithelium. In another embodiment, the radiofrequency electrode canbe either monopolar or bipolar. In the monopolar mode, radiofrequencycurrent flows through body tissue from a return electrode which can bein the form of a conductive pad applied to another portion of thepatient's body. The distal end of the treatment tip may have a pair ofmonopolar electrodes, a bipolar pair, or multiple bipolar pairs.

In one embodiment, the electrode may be equipped with an integratedEEROM (Electrically Erasable Read Only Memory, also known as EEPROM)programmable memory chip at any suitable location within the treatmenttip. Such a chip may provide identifying information or otherinformation about the operational status or configuration parameters ofthe radiofrequency electrode to the system, such parameters may include,by way of example, the type and size of the electrode, the number oftimes the energy delivery element has been fired, and the like.

Treatment Surface

In one embodiment, the distal end of the treatment tip is configured tobe conical, spherical, hemispherical or of any other desirable geometry,providing a treatment surface that is suitable for the treatment site.Energy delivery elements are located on the treatment surface at thedistal end of the treatment tip. For example, the energy deliveryelements can be arranged on the treatment surface at the distal end of atreatment tip that may be conical, spherical, hemispherical, oval,circular or any other desirable geometry. One of ordinary skill in theart would readily design treatment surface (conical, spherical, etc.)and energy delivery elements in different sizes (e.g. small, medium andlarge) to accommodate anatomical differences of the female genital.

The energy delivery elements (or electrodes) can be arranged on thetreatment surface in a number of different patterns or array (FIGS.1-2). For example, the electrodes may or may not occupy the entiretreatment surface. One of ordinary skill in the art would readilyconfigure the dimensions of the energy delivery elements to suit thetreatment needs and the configuration of the treatment tip so that thetreatment surface and the electrodes would adequately cover the anatomyof the target tissue. By dividing the electrodes into multiple arraysand through the use of sensory technology, an operator may determinewhich array areas are making appropriate tissue contact and then deliverradiant energy to those specific electrodes.

In one embodiment, certain areas on the treatment surface are covered byan insulated material, not the energy delivery elements; therefore, theelectrodes or energy delivery elements are absent from certain areas onthe treatment surface (FIGS. 1-2). This allows the user to avoidtreating certain areas of the tissue under treatment to improve thesafety and effectiveness of the treatment.

In another embodiment, the electrodes are present throughout thetreatment surface, but specific electrodes can be turned on/off so thattreatment is avoided in certain portions of the tissue under treatment.

In yet another embodiment, the electrodes can be turned on and off inany sequence or pattern to provide treatment to the target tissue. Forexample, the electrodes may be turned on and off in a clockwise orcounter-clockwise direction. In another embodiment, through remotecontrol by means of a user interface, specific electrodes can be turnedon and off in any sequence or pattern. In yet another embodiment,software programs can be used to track which electrodes have been turnedon and turned off to identify and segregate untreated areas from treatedareas.

Cooling Mechanism

In one embodiment, the interior space of the distal end of the treatmenttip accommodates a cooling system to cool the energy delivery elements.For example, the interior space comprises a cooling lumen for conveyingcoolant to a plurality of nozzles. Various coolants are known in theart, e.g. 1,1,1,2-tetrafluoroethane (R134A) or carbon dioxide, which canbe stored in a reservoir under pressure. The nozzles are typicallylocated opposite to the internal surface of the energy deliveryelements. The coolant, upon release from the nozzles, is sprayed ontothe internal surface of the energy delivery elements and cools theenergy delivery elements as the coolant undergoes a liquid to gastransformation. Consequently, the exterior surface (theepithelium-contacting surface) of the energy delivery elements wouldcool the epithelial tissues in contact with said surface.

One of ordinary skill in the art would recognize that any appropriatecoolant and internal cooling system may be used. In some variations, thecooling may be electrical (e.g., via Peltier effect or the like). Thus,in general, the cooling system of the treatment device may include acooling chamber. The cooling chamber may include one or more nozzles forspraying or applying coolant. Coolant may be applied in any appropriatepattern to the internal surface of the energy delivery elements. Forexample, the spraying pattern may be overlapping circles. In FIG. 3, theenergy delivery elements are located on a cone-shaped treatment surface,and the nozzles are spaced opposite to the internal surface of theenergy delivery elements and emit a cone-shaped spray pattern.

Thus, in general, the cooling chamber has a plurality of nozzles forapplying coolant onto the internal surface of the energy deliveryelements. Since the internal surface of the energy delivery elements isthermally conductive, cooling the internal surface (even a portion ofthe internal surface) will result in cooling the outer surface of theenergy delivery elements, and thereby cooling the epithelial tissue incontact with the energy delivery elements.

Hand Piece

In general, the hand piece is sufficiently long to be easily held by twohands. The hand piece may be relatively rigid (as compared to theflexible, typically flat cable, for example). In one embodiment, thehand piece (1101) is elongated, and includes a grip region (1003) (FIG.4). The hand piece may also include one or more controls such as abutton, slider, dial, or the like. The control may allow the user toapply energy to the energy delivery elements, to apply coolant, or both.The hand piece may also include one or more indicators for indicatingthe status and/or orientation of the device, such as the treatment tip.For example, an indicator may indicate whether or not the treatment tipis attached; whether or not the device is out of coolant;

or whether or not the device is ready for activation. In anotherembodiment, an indicator may indicate the temperature of the treatmenttip (e.g., the energy delivery elements), and/or the duration of timethat the device has been active. In some variations, the indicatorincludes one or more lights (e.g., LEDs, etc.), colors (includingcolored lights), alphanumeric display (e.g., a display screen ormonitor), or the like. The hand piece is typically configured to couplewith the treatment tip. In some variations, the treatment tip isconfigured to be capable of quickly or easily attached to and detachedfrom the handle.

In one embodiment, either the hand piece or the treatment tip, or both,may include markers that indicate how deep into the vagina the devicehas entered. This may allow the user to maintain a desired depth ofoperation.

In one embodiment, the treatment tip is designed as a single-usedisposable component, while the hand piece is typically reusable.Accordingly, the entire treatment tip and its parts are to besterilized, and individually packaged to maintain sterilized until thepackage is opened, and the treatment tip is attached to a hand piece inpreparation for use.

Electronic Support System for the Device

The device described above for remodeling female genital tissue may beincluded in a larger electronic system. The system may include a powersource, such as a radiofrequency power source that provides energy tothe radiofrequency electrodes. The system may also include a multiplexerdriven by a controller, which can be a digital or analog controller, ora computer. When the controller is a processor (such as a microprocessorof a computer), it can include a CPU coupled through a system bus. Theremay also be a keyboard, disk drive, or other nonvolatile memory systems,a display, and other peripherals on the system. A program memory and adata memory may also be coupled to the bus.

In another embodiment, the electronic support system may include anoperator interface comprising operator controls and a display. Theoperator controls can be coupled to different types of imaging systemsincluding ultrasonic and impedance monitors. Current and voltage areused to calculate impedance. A diagnostic phase can be initially run todetermine the level of treatment activity. This can be done throughultrasound as well as other means. Diagnostics can be performed bothbefore and after treatment.

One of ordinary skill in the art would readily design an appropriateelectronic support system for the device. Circuitry, software andfeedback to controller result in full process control and are used tochange power, the duty cycle, monopolar or bipolar energy delivery, flowrate and pressure, and can also determine when the process is completedthrough time, temperature and/or impedance. Furthermore, a controllercan provide multiplexing, monitor circuit continuity, and determinewhich radiofrequency electrode is activated. When the values exceed thepredetermined temperature or impedance values, a warning can be given onthe display. Additionally, the delivery of radiofrequency energy to theelectrodes under warning can be decreased or multiplexed to anotherelectrode.

System for Remodeling Target Tissues

In one embodiment, a vaginal remodeling system (hereinafter called‘system’) may include a hand piece, a disposable (or reusable) treatmenttip, a power source or supply, a cooling sub-system, and a controller.In some variations, the controller, power supply or source and coolingsub-system may be integrated into a single unit to which the hand pieceand treatment tip may be coupled (FIGS. 5A and 5B). The integratedsystem (1500) in this example includes a display (1501) and a housing(1503) to which the hand piece (1505) and treatment tip (1507) areattached via a cable (1509). The cable may include supply and returncoolant lines, as well as a connection to the radiofrequency energysupply and any sensors on the treatment device. This entire system maybe configured for ease of use, including portability and compactarrangement.

For example, in one variation, the system may include: a treatment tip(for delivery of radiofrequency energy), a source of coolant (e.g.,cryogen), a hand piece, a cable connecting the hand piece and treatmenttip to the source of coolant, power source, and/or control system or acontroller.

In one embodiment, the hand piece is connected via a single cable to anintegrated controller, which includes both a cooling system and powersource that may be controlled or regulated by the controller. The cablemay include supply and return coolant lines, as well as a connection tothe radiofrequency energy supply and any sensor(s) on the treatmentdevice.

In one embodiment, the integrated system may include an opening intowhich a coolant may be inserted. For example, the coolant may be apressurized canister (1521) of any appropriate cryogen. The coolantcanister may be threaded with one or more sets of threads to secure itinto place in the integrated system, although any appropriate sealingmechanism for the coolant may be used. The level of coolant may bemonitored by the system, and the display may include an icon indicatingthe level of coolant remaining in the canister or system.

In one embodiment, the components of the integrated controller include amicroprocessor (which may include hardware, software, and/or firmware)for controlling the system, any outputs (e.g., monitor, one or morespeakers, etc.), the radiofrequency power source, and the coolingsub-system. These different components of the integrated controller maybe individually installed within the housing in a “modular” manner.

The overall weight and footprint of the integrated system, andparticularly the integrated controller, may be sufficiently small sothat the system for tissue remodeling is portable and readily storable.For example, the entire system may weigh less than 50 pounds.

The system may also include one or more controls for controlling thedevice. In particular, the system may include a control for controllingthe energy delivery of the treatment device (e.g., activation control),as well as one or more controls for controlling the treatment regime.

The controller may include a display that is configured to displayinformation about the procedure, the coolant, the treatment tip, handleand other components of the system. This information may be displayed onthe front of the integrated controller, and may present the informationwith audio signals as well. The display may also be used to displayerror information (including error codes) based on the status of thevarious system component (e.g., coolant level, contact with skin,radiofrequency generator status, etc.) In one embodiment, the displayscreen is a touch screen that allows the user to select treatmentparameters by touching the screen. In some variations, the system mayinclude a keyboard, mouse, trackball, or the like.

In some variations, the activation control is on the hand piece, e.g. abutton. In one embodiment, the system may include a wired or wirelessfoot switch or other control that is separate from the hand piece. Inone variation, the foot switch is connected to the integrated control.

Temperature Sensors

One of the factors that need to be controlled during treatment is thetemperature of the area being treated. This can be achieved through atemperature sensor such as a thermocouple. All temperature sensors knownin the art can be used. A sensory device such as a thermocouple works bycomparing the difference in temperature between two junctions. One ofthe junctions is a reference junction and the other is placed at thetarget area.

In one configuration of the invention, a junction of a thermocouple isplaced on the treatment electrode/energy delivery dements. For example,to measure temperature on the surface of the genital tissue, a junctionis designed to be a short blunt needle that is innocuous and would notcause injury to the tissue (FIG. 6A). Alternatively, to measuretemperature underneath the epithelium, a junction is designed tocomprise a needle that penetrates the epithelial tissue and reaches aspecific depth of the target tissue where temperature data is gathered(FIGS. 6B-6C).

In one embodiment, the junction in contact with the target tissue may bepositioned at the distal end or center of the energy delivery elements,or close to the proximal end of the hand piece (FIGS. 6A-6C).

In another embodiment, there may be more than one pair of temperaturemeasuring junctions placed on the energy delivery elements in contactwith the target tissue. This will allow for comparative temperaturemeasurements or for temperature monitoring across the energy deliveryelements.

In one embodiment, the reference junction of the thermocouple that isnot contacting the tissue may be placed between the energy deliveryelements and the hand piece, or on the hand piece.

Feedback obtained from the temperature measurement can be fed into acontrol unit and be displayed, and/or used for producing alarms asnecessary. The temperature feedback may also be used to assess treatmenteffectiveness or to shut off the treatment when a target temperature hasbeen reached or exceeded. The alarms and messages may be in the form ofvisual readouts and/or audio outputs.

Directional Sensors

In a typical treatment procedure, the energy delivery elements on thedistal end of the treatment tip can contact various sites in the lowervagina. A set of contact sites would collectively form a treatment areaon the vaginal epithelium. The energy delivery elements (or thetreatment surface comprising the energy delivery dements) can be appliedto the contact sites or treatment area in many ways. For example, theenergy delivery elements can treat the contact sites in a clockwise orcounter-clockwise manner, or at pre-determined time intervals. Sincetreatments may vary from patient to patient, or even within the samepatient, directional sensors are integrated into the device to providethe user with appropriate information on the position of the treatmenttip. In one embodiment, sensory information may be Obtained from morethan one sensor in the tissue remodeling system, and the sensoryinformation from each sensor can be used individually or collectively.

A number of sensory feedback mechanisms generally known in the art canbe used in the present invention. In one embodiment, the sensoryfeedback may be obtained through electromagnetic sensory mechanisms orthrough sensors like accelerometers or gyroscopes, where an initialposition is noted and any changes in position are noted by changes indistance, angle or other comparative means, such as changes in yaw,pitch, or roll etc.

In another embodiment, sensory feedback can also be obtained throughoptical means through the measurement of light. For example, opticalencoder discs are used to measure changes in position using a lightsource and photo or reflective sensors.

In another embodiment, sensory feedback can also be obtained throughoptical means through the measurement of light. For example, opticalencoder discs are used to measure changes in position using a lightsource and photo or reflective sensors.

In one embodiment, the directional sensors may be positioned proximallyor distally on the hand piece (FIGS. 7A-B). In another embodiment, thesensors can be positioned near the energy delivery elements on thetreatment tip (FIG. 7C).

In one embodiment, sensory information from the directional sensors isprocessed and displayed to alert users as to the current position of thetreatment tip, other positions it has been in, the direction oftreatment and other pertinent information.

In another embodiment, sensory information obtained from a treatmentdevice may activate alarms indicating if the treatment device isapproaching a new treatment site, if it is traversing a site that hasalready been treated, or if there has been a change in the treatmentdirection.

Sensory information regarding the treatment process for a given patientmay be stored as reference and used for comparison in future treatmentsor other purposes.

Sensory information obtained from the directional sensors would havemany applications. For example, it provides information on the specificlocation of the treatment device on the treatment area. In treatingpatients, it may be necessary to vary the energy delivery scheme, thequantity of energy delivered, coolants or other components used toassist treatment, etc. Thus, the position of the treatment device on thetreatment area can be used for one or more purposes:

-   -   1. The position of the treatment device may indicate whether or        not treatment or any supplementary components would be        necessary. Thus, information regarding the position can be used        to determine whether the treatment should be started or stopped,        and if use of any supplementary materials (e.g. coolants) need        to be started or stopped.    -   2. The position of the treatment device may be used to vary the        amount of energy delivered, or the amount of any supplementary        materials used. These changes may improve the efficiency and        safety of the treatment. Thus, based on the changes in the        position of the device, and the direction of movement of the        device towards specific treatment areas, various treatment        parameters may be changed.    -   3. The changes in the treatment materials and/or parameters can        either be programmed directly into the treatment control device,        or be manually controlled if necessary.

Depth Markers

In one embodiment, the tissue remodeling device described above can beused to treat vagina of different shapes and depths. The depth at whichthe treatment surface at the distal end of the treatment tip penetratesthe vagina or other target tissue can affect the safety and/oreffectiveness of the treatment. Accordingly, markers on the treatmentdevice allow a user to quickly assess the depth at which the treatmentsurface/treatment device has penetrated the vagina. The location of themarkers will depend on the configuration of the device itself.

In one embodiment, scale markers accompanied by raised reference linesor other similar features help the user either visually or through senseof touch to determine the depth of penetration. Alternatively, the scalemarkers are indented instead of raised. In another embodiment, the scalemarkers can be raised markers on one side of the treatment tip and beindented markers on another side. Any of the above marker schemes can beplaced on one or more sides of the treatment tip to help the usermanipulate the device while maintaining it at a specific depth withinthe vagina.

In case the distal end of the treatment tip is conical (or spherical,circular, etc.) in shape, depth markers (8) can surround the treatmentsurface or cover part of the surface (FIG. 8A). This will be useful whenthe treatment device is rotated or inserted during the treatmentprocess.

In one embodiment, numerals can be used as depth markers to show thedepth of penetration (FIGS. 8A, 8B). This numeric scale can includenumbers and unit of measurement such as inches, millimeters orcentimeters. These numbers can be printed on the treatment tip, flushwith the surface of the treatment tip. In another configuration, thenumbers may be raised or indented to enhance the visual effect and senseof touch.

The numeric markers may also be printed with colors that substantiallycontrast the color of the treatment tip. For example, if the treatmenttip is black, the markers could be white, or vice versa. This colorcontrast will allow for easy visual recognition of the treatment depth.

In another embodiment, the numbers and markers can he staggered inmultiple colors to display different depths of penetration, such asusing three different colors to depict shallow, medium or deep.

In another embodiment, the numbers and markers can be staggered with twodifferent colors as safety indicators. A certain depth may be consideredsafe, and this may be indicated using green color for example, and adepth considered unsafe may be indicated using red. Other contrastingcolors could also be used.

In summary, markers located on the treatment tip enable the user toquickly determine if the tissue remodeling treatment tip has reached thedepth of the target vaginal tissue. The markers and numerals are locatedon the treatment surface at the distal end of the treatment tip. Inanother embodiment, the markers are near the proximal end of thetreatment tip. In yet another embodiment, the markers could be locatedat multiple positions on the treatment tip for added convenience.

Device with Finger Holder

In one embodiment, the treatment device comprises a gripping means (14)and a hand piece (2), wherein the gripping means is connected to thehand piece, wherein the gripping means has a finger holder (12) at theproximal end, and a wrapping loop (15) at the distal end, wherein thefinger holder is connected to a housing (13), and the surface of thehousing comprises at least one energy delivery element (4) (FIG. 9).

In one embodiment, the finger holder is connected to a rod and a strapthat can wrap around the user's hand or arm so that the device may beheld firmly (e.g. a wrist band, see FIG. 9). This will allow the user toaccess and withdraw from the treatment site without losing the grip,thus promoting safety, treatment effectiveness and user comfort.

In one embodiment, the finger holder (12) is connected to the hand piece(2) via wires (16) to deliver electricity, radiofrequency, coolantand/or digital signals. The housing (13) is rectangular, curved, oval,conical, hemispherical, spherical or circular in shape.

In another embodiment, the finger holder is connected to the hand piecewithout the rod and wristband (FIG. 10). This will allow a user to pullhis/her finger out of the finger holder and just grasp the hand pieceafter the energy delivery elements have been placed into the treatmentsite. The treatment device comprises a finger holder (12), a hand piece(2) and a connection means (3), wherein the finger holder is coupledthrough the connection means to the distal end of the hand piece,wherein the finger holder is connected to a housing (13), and thesurface of the housing comprises at least one energy delivery element.

In one embodiment, the finger holder can be designed to accommodate awide variety of finger sizes, both male and female. One way to achievethis would he through the use of finger holders and electrodes ofmatching sizes, or the use of sleeves of different internal diametersinside the finger holder. Another approach is making the finger holderwith soft materials that will adapt to various finger sizes. The fingerholder will allow the physician/user/treatment provider to easily reachthe treatment site, thus achieving different advantages such as accuracyand speed of treatment.

In one embodiment, the energy delivery elements are part of a housingthat accommodates a cooling chamber to cool the energy deliveryelements. For example, the cooling chamber may comprise a cooling lumenfor conveying coolant to one or more nozzles. Various coolants are knownin the art, e.g. 1,1,1,2-tetrafluoroethane (R 134A) or carbon dioxideWhich can be stored under high pressure. The energy delivery elementscomprise an epithelium-contacting surface and an internal surface facingthe cooling chamber. In one embodiment, the nozzles are located oppositeto the internal surface of the energy delivery elements. The coolant,upon release from the nozzles, is sprayed onto the internal surface ofthe energy delivery elements and cools the surface as a result ofvaporization. Consequently, the exterior epithelium-contacting surfaceof the energy delivery elements would cool the epithelial surface of thetarget tissue.

Treatment of target tissue is achieved by inserting a finger into thefinger holder and directly applying the energy delivery elements ontothe treatment site. The energy delivery elements can be moved in aclockwise or counter-clockwise direction on the treatment site. One ofordinary skill in the art would readily configure the dimensions andsizes of the energy delivery elements to provide optimal treatment.

In one embodiment, the energy delivery element may be a radiofrequencyelectrode, a microwave emitter, or an ultrasound emitter. In oneembodiment, the radiofrequency electrode is a capacitive electrode incontact with the mucosal epithelium.

1-20. (canceled)
 21. A device for remodeling the female genital tissue, comprising a treatment tip and a hand piece, wherein the treatment tip is connected to the distal end of the hand piece via a connection means, wherein the distal end of the treatment tip is rectangular, curved, conical, spherical, hemispherical, oval or circular in shape, and has a surface comprising one or more energy delivery elements, wherein said elements have an internal surface and an epithelium-contacting surface, and wherein the device further comprises one or more of the following: (a) one or more temperature sensors for measuring the temperature at or below the epithelium; (b) one or more directional sensors; and (c) one or more depth markers showing the depth of penetration of the treatment tip into the vagina.
 22. The device of claim 21, wherein said treatment tip is equipped with a finger holder.
 23. The device of claim 21, wherein the energy delivery elements can be turned on and off selectively.
 24. The device of claim 21, wherein the surface at the distal end of the treatment tip is fully or partially covered by energy delivery elements.
 25. The device of claim 21, wherein the surface at the distal end of the treatment tip is partially covered by insulated material.
 26. The device of claim 21, wherein the inside of said treatment tip comprises an internal cooling chamber having a supply line of coolant opposite to the internal surface of said one or more energy delivery elements, wherein the supply line of coolant comprises a plurality of nozzles configured to spray a coolant onto the internal surface of said one or more energy delivery elements.
 27. The device of claim 21, wherein the hand piece comprises one or more indicators for indicating the status and/or orientation of the device.
 28. The device of claim 21, wherein the treatment tip is removable from the hand piece.
 29. The device of claim 21, wherein the temperature sensors are thermocouples, each comprising a first and a second junction.
 30. The device of claim 29, wherein the first junction is located on the hand piece or between the energy delivery elements and said hand piece, and wherein the second junction is located at the distal end, proximal end, or middle of the one or more energy delivery elements.
 31. The device of claim 29, wherein the second junction comprises a blunt end that contacts the epithelium and measures its temperature, or a needle that penetrates the epithelium and measures the temperature below the epithelium.
 32. The device of claim 21, wherein one or more of said directional sensors employ electromagnetic or optical mechanisms to track the position of the treatment tip.
 33. The device of claim 32, wherein said directional sensors employing electromagnetic mechanisms are accelerometers or gyroscopes.
 34. The device of claim 21, wherein the directional sensors are mounted proximally or distally on the hand piece, or mounted close to the one or more energy delivery elements on the treatment tip.
 35. The device of claim 21, wherein the depth markers comprise raised lines, indented lines or numerical markers, and are located on the surface at the distal end of the treatment tip.
 36. A system for remodeling the female genital tissue, comprising i) a hand piece; ii) a treatment tip, wherein the treatment tip is connected to the distal end of the hand piece via a connection, wherein the distal end of the treatment tip is rectangular, curved, conical, spherical, hemispherical, oval or circular in shape, and has a surface comprising one or more energy delivery elements, wherein said energy delivery elements have an internal surface and an epithelium-contacting surface, and wherein the device further comprises one or more of the following: (a) one or more temperature sensors for measuring the temperature at or below the epithelium; (b) one or more directional sensors; and (c) one or more depth markers showing the depth of penetration of the treatment tip into the vagina; and iii) an integrated controller comprising (a) a housing; (b) a radiofrequency power source within the housing; (c) a cooling sub-system within the housing; (d) a controller for controlling the operation of the system; and (e) a display configured to display information about the system.
 37. The system of claim 36, wherein the energy delivery elements can be turned on and off selectively.
 38. The system of claim 36, further comprising a cable connecting the hand piece and the integrated controller, and/or a foot switch configured to connect to the integrated controller.
 39. A method of using the device of claim 21 for remodeling a target tissue underlying a mucosal epithelium of the female genital tissue, comprising the step of cooling said epithelium and heating said target tissue with said energy delivery elements.
 40. The method of claim 39, wherein remodeling includes contracting the target tissue, tightening the introitus, tightening the vagina, denaturing collagen, or tightening collagen-rich sites of the target tissue. 